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NCT Number: NCT07577934

Efficacy of Liposomal Bupivacaine for Transversus Abdominis Plane Block

This is a single-center, randomized, single-blind, parallel-group clinical trial. The study aims to compare the analgesic efficacy of liposomal bupivacaine versus ropivacaine for transversus abdominis plane (TAP) block in patients undergoing laparoscopic cholecystectomy. Eligible participants will be randomly assigned to receive either liposomal bupivacaine or ropivacaine for TAP block during surgery. The primary outcome is the dynamic NRS pain score at 24 hours after surgery. Secondary outcomes include static and dynamic NRS pain scores at multiple time points, QoR-15 recovery quality, time to first rescue analgesia, analgesic consumption, gastrointestinal function recovery, length of hospital stay, and adverse events. Participants will be followed up to 3 months after surgery to evaluate the incidence of chronic post-surgical pain (CPSP). All participants will receive routine clinical care, and participation is voluntary.

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Key information

Conditions

Postoperative Pain Liposomal Bupivacaine Neurologic Manifestations Pain Pain, Postoperative Pathologic Processes Pathological Conditions, Signs and Symptoms Postoperative Complications Signs and Symptoms

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Tianjin First Central Hospital

Tianjin, Tianjin Municipality, 300384, China

Location status: Recruiting

Location contact

Lili Jia

CONTACT

[email protected]

+86 13102058301

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Age 18-65 years, either gender.
  • Patients scheduled for elective laparoscopic cholecystectomy.
  • ASA physical status I-III.
  • Able to provide written informed consent and complete the 3-month follow-up.

Exclusion criteria

  • History of allergy to local anesthetics.
  • History of dementia, psychosis, or other central nervous system diseases.
  • History of chronic pain or long-term use of opioids or other analgesics.
  • Contraindications to nerve block: infection at puncture site, severe coagulopathy.
  • Severe hepatic or renal dysfunction, pregnancy, or lactation.

Treatment and study plan

Liposomal Bupivacaine TAP block

Drug

Liposomal bupivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.

Ropivacaine TAP blocks

Drug

Standard-dose ropivacaine administered via ultrasound-guided transversus abdominis plane (TAP) block after laparoscopic cholecystectomy.

Primary outcomes

  1. Postoperative dynamic NRS pain score at 24 hours

    Time frame: 24 hours after surgery

    Postoperative pain intensity under dynamic conditions (e.g., coughing or deep breathing) will be assessed using the Numerical Rating Scale (NRS, 0-10, where 0 = no pain and 10 = worst imaginable pain).

Secondary outcomes

  1. Postoperative NRS pain scores at different time points

    Time frame: 24, 48, and 72 hours after surgery

    NRS scores at 24, 48, and 72 hours post-surgery while at rest; NRS scores at 48 and 72 hours while active

  2. Postoperative recovery quality (QoR-15 scale)

    Time frame: 24, 48, and 72 hours after surgery

    Postoperative recovery quality will be evaluated using the 15-item Quality of Recovery (QoR-15) scale at 24 hours after surgery. The total score ranges from 0 to 150, with higher scores indicating better recovery quality.

  3. Time to first rescue analgesia

    Time frame: Up to 72 hours after surgery

    The time from the end of surgery to the first request for rescue analgesia (e.g., opioid or non-opioid analgesics) will be recorded（background pain is excluded）.

  4. Total postoperative analgesic consumption within 72 hours

    Time frame: 72 hours after surgery

    Total amount of rescue analgesics (e.g., opioids, NSAIDs) used by each patient within 72 hours after surgery will be calculated and converted into equivalent doses.

  5. Gastrointestinal function recovery

    Time frame: Postoperatively, through hospital discharge, up to 7 days after surgery

    Time to first flatus and time to first defecation, measured from the end of surgery.

  6. Postoperative length of hospital stay

    Time frame: Postoperatively, through hospital discharge (up to 7 days)

    The total number of days from surgery to hospital discharge will be recorded.

  7. Incidence of adverse events

    Time frame: Postoperatively, through hospital discharge, and at follow-up (up to 7 days after surgery)

    Adverse events including nausea, vomiting, dizziness, local anesthetic toxicity, and neurological complications will be recorded and compared between groups during hospitalization and follow-up.

Other outcomes

  1. Incidence of chronic post-surgical pain (CPSP) at 3 months

    Time frame: 3 months after surgery

    The incidence of chronic post-surgical pain will be assessed via telephone follow-up.Incidence of chronic post-surgical pain (CPSP) , defined as persistent pain (NRS ≥ 1) at the surgical site lasting ≥ 3 months after laparoscopic cholecystectomy, excluding pain caused by other etiologies.

Study contacts

Contact information is provided by the study sponsor or research team.

Ke yu Zhang

CONTACT

[email protected]

+86 19861121816

Lili Jia

CONTACT

[email protected]

+86 13102058301

Sponsors and collaborators

Lead sponsor

Tianjin First Central Hospital

Other

Registry information

Official study title

Liposomal Bupivacaine Versus Ropivacaine for Transversus Abdominis Plane Block in Laparoscopic Cholecystectomy: A Randomized, Single-Blind, Parallel-Group Trial

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 11, 2026
Registry last updated
May 14, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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